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Quality Systems & Compliance Manager

Description

Responsible for strategizing, planning, communicating, and maintaining a comprehensive Quality Systems and Compliance infrastructure requirements in accordance with current applicable local, international, corporate and company’s Quality Systems and relevant process requirements.

As part of the job:
• Leads the Quality Systems processes in Biosense Webster (Israel) such as CAPA, Complaints Management, Management Reviews, Documentation Control, Training, Technical Communication, External Standards and Computerized System Life Cycle through collaboration with multidisciplinary global and local partners to cascade quality culture and continuous improvement across the organization
• Drives effective CAPA Processes while meeting and maintaining company established Metrics goals for CAPA measures.
• Maintains High Level of Customer Complaint Management Processes
• Leads the Documentation team to ensure company compliance with documentation and training procedures and practices
• Takes leadership role in Internal and External audits
• Team management of diverse professional teams, including hiring, mentoring, developing, and training
• Ensures a full compliance with all company’s policies, procedures, and guidelines

Requirements

• Engineering degree or from the fields of science - required. Master's degree in engineering or quality assurance - an advantage
• Certification as a CQE and / or auditor – an advantage
• At least 5 years of experience as a Quality Manager / Leader in a global organization in the Medical Devices Industry
• Experience in managing and leading teams
• Experience in managing international multi-disciplinary projects
• Experience in quality audits management and statistical analysis
• knowledge in ISO13485 and Quality system regulation 21 CFR part 820
• English at a very high level - required

Location: יקנעם